Apparatus for use in surgery and a valve

ABSTRACT

Apparatus for use in surgery comprises a sleeve ( 1 ) having an entry opening ( 4 ) at an outer end and an exit opening. ( 5 ) at an inner end to access a patient&#39;s body. Exit sealing means  10  are provided for sealing the exit opening ( 5 ) to a body entry sealing means ( 20 ) are provided for sealing the outer entry against an arm passing therethrough to create a controlled environment within the sleeve.  
     A valve ( 101 ) comprises an outer ring ( 105,106 ) and a sealing sleeve ( 107 ) of flexible material mounted to the ring ( 105,106 ) and extending into the opening defined by the ring to terminate in a substantially centrally disposed inlet opening ( 108 ). Through the opening ( 108 ) a member such as a trocar ( 103 ) or surgical instrument may be passed. The sealing sleeve ( 107 ) remains in sealing engagement, with the member ( 103 ) as it is passed therethrough.

[0001] The invention relates to an apparatus for use in surgery and inparticular to an apparatus to be used in minimal invasive surgery inwhich surgery is carried out by making the minimum number of incisionsin a patient's body.

[0002] The invention also relates to valve, and in particular to a valvefor use with a trocar assembly.

[0003] Abdominal surgery is generally carried out by making a very largeincision allowing a surgeon to enter the body cavity

[0004] with both hands. Such surgery is traumatic for the patient andthe healing process is lengthy. Some laproscopic surgery such as herniaoperations may be carried out by surgeons using minimal invasivetechniques with trocar assemblies. However, the techniques are generallycomplex and difficult and are not widely used.

[0005] Trocars are short pointed instruments used to puncture a bodycavity. A cannula may be inserted into the opening created by a trocarto drain the fluids from the body. Trocars may also be used duringendoscopic procedures. Trocar assemblies are described in U.S. Pat. Nos.4,601,710 and 4,654,030.

[0006] Because of the wide range of instruments which pass throughtrocar tubes or trocar assemblies, a large variety of different diametertubes and instruments are required. Various attempts have been made toprovide a valve to allow a range of different sizes of instruments topass through a single trocar tube. These efforts to date however havenot been entirely successful.

[0007] There is therefore a need for an improved valve particularly fora trocar tube or cannula which will overcome this problem. Thisinvention is directly towards providing such a valve.

[0008] According to one aspect of the invention there is provided anapparatus for use in surgery comprising a sleeve having an entry openingat an outer end thereof and an exit opening at an inner end thereof toaccess a patient's body, exit sealing means being provided for sealingthe exit opening to a body and entry sealing means being provided forsealing the outer entry against an arm passing therethrough to create acontrolled environment within the sleeve.

[0009] In a particularly preferred embodiment of the invention thesleeve is of a flexible material. Most preferably, the sleeve is of agas-impermeable material to create a controlled pressurised environmentwithin the sleeve.

[0010] In a particularly preferred embodiment of the invention thesleeve comprises a generally cylindrical body closed at one end thereofand an exit opening is provided in a side wall of a body adjacent theclosed end.

[0011] In one arrangement the exit sealing means comprises a flangearound the exit for sealing against the body of a patient. Preferablythe flange is provided with an adhesive for adhering to the body.Typically the exit and flange are covered by a peel-off cover.

[0012] In another arrangement the flange is engaged with a mounting ringsurrounding an incision in a patient's body.

[0013] The, entry sealing means may comprise a valve means through whicha surgeon passes an arm. Preferably the valve means is of a materialwhich is sufficiently flexible to allow an arm to be passed therethroughand to seal against the arm when passed therethrough.

[0014] Alternatively, the means comprises a first mounting in the sleeveentry, a second mounting and a sealing body of flexible materialextending between the mountings, one of the mountings being twistedrelative to the other two to twist the sealing body into engagement withan arm passing therethrough.

[0015] In one arrangement fixing means are provided for fixing onemounting relative to the other in the sealing position. Typically thefixing means comprises inter-engaging formations provided on themountings.

[0016] In another arrangement the first mounting comprises a ringmounted in the sleeve at: the entry thereof.

[0017] In a particularly preferred arrangement the second mountingcomprises a ring to which the sealing material is attached.

[0018] In one embodiment of the invention the entry sealing meanscomprises a first sealing element provided in the entry and a secondsealing entry provided, on a surgical glove, the sealing elementsinter-engaging to seal the sleeve on passing of the glove through theentry.

[0019] According to another aspect of the invention there is provided avalve comprising an outer ring and a sealing sleeve of flexible materialmounted to the ring and extending into the opening defined by the ringto terminate in a substantially centrally disposed inlet opening throughwhich a member such as a trocar or surgical instrument may be passed,the sealing body remaining in sealing engagement with the member as itis passed therethrough.

[0020] In a particularly preferred embodiment of the invention, thesealing body is twisted into a substantially hourglass shape having acentral opening through which a member is passed.

[0021] Preferably the ring comprises a pair of axially facing ringparts, opposite free ends of the flexible sealing sleeve being attachedto the respect ring parts, one of the ring parts being rotated relativeto the other to twist the sealing sleeve into a twisted sealingconfiguration and fixed relative to the other ring part in the sealingconfiguration.

[0022] The invention also provides a trocar tube or cannulaincorporating a valve according to the invention. The invention furtherprovides a trocar assembly incorporating a trocar tube or cannulaaccording to the invention and/or a valve according to the invention.

[0023] The invention will be more clearly understood from the followingdescription thereof, given by way of example only with reference to theaccompanying drawings in which:—

[0024]FIG. 1 is a plan view of a sleeve;

[0025]FIG. 2 is a cross-sectional view of the sleeve of FIG. 1;

[0026]FIG. 3 is a plan view of a sleeve with an entry sealing means inposition;

[0027]FIG. 4 is a perspective view of the sleeve of FIG. 3 in use;

[0028]FIG. 5 is a perspective view of the entry sealing means used inthe sleeve of FIGS. 3 and 4 in an open configuration;

[0029]FIG. 6 is a side elevational view of the sealing means of FIG. 5in an intermediate position;

[0030]FIG. 7 is a perspective view of the sealing means of FIG. 5 in asealed configuration;

[0031]FIG. 8 is a perspective view of another sleeve according to theinvention; and

[0032]FIG. 9 is a side cross-sectional view of a further sleeveaccording to the invention.

[0033]FIG. 10 is a side cross-sectional view of one further sleeveaccording to the invention and

[0034]FIG. 10a is a rear end view of the sleeve shown in FIG. 10;

[0035]FIG. 11 is a diagrammatic exploded perspective view of a trocarassembly incorporating a valve according to the invention;

[0036]FIG. 12 is a cross sectional view of a valve used in the assemblyof FIG. 1;

[0037]FIG. 13 is a perspective view of a trocar tube incorporating thevalve;

[0038]FIG. 14 is a cross sectional view of the trocar and valve in use;

[0039]FIG. 15 is a cross sectional view of a modified arrangementaccording to the invention in one position of use; and

[0040]FIG. 16 is a cross sectional view of the arrangement of FIG. 15 inanother position of use.

[0041] Referring to the drawings and initially to FIGS. 1 to 7 thereof,there is illustrated an apparatus for use in surgery according to theinvention indicated generally by the reference numeral 1. The apparatus1 comprises a sleeve 2 of flexible gas-impermeable material. The sleeve2 in this case comprises a generally cylindrical body closed at one end3 thereof and open at the other end 4 thereof to define an entry openingat an outer end for passage of an instrument and/or surgeon's arm. Anexit opening 5 is provided in a side wall of the sleeve 2 as illustratedparticularly in FIG. 2 to provide an access point for entering apatient's body through an incision therein.

[0042] Exit sealing means 10 for sealing the exit opening 5 to apatient's body is in this case provided by a flange 11 around the exitopening 5 to the outer face of which is applied a pressure sensitiveadhesive for adhering to the body of the patient. The adhesive side ofthe flange 11 is covered prior to use with a peel-off cover 12.

[0043] Entry sealing means which for clarity is not illustrated in FIGS.1 and 2 is in this case provided by a valve means indicated generally bythe reference numeral 20 and illustrated particularly in FIGS. 3 to 7.The valve means 20 comprises a first mounting provided by a ring 21attached to the body of the sleeve 2 at the entry 4 and a secondmounting provided by another ring 22 which is attached to the first ring21 by a sealing member 23 of flexible material extending between therings.

[0044] The outer ring 22 with the flexible body 23 attached is rotatedto twist the sealing body 23 in the direction of the arrow X illustratedin FIG. 6 to engage and seal against a surgeon's arm 30 passingtherethrough. When the sealing member 23 is in sealing engagement theouter ring 22 is pushed forwardly in the direction of the arrow Yagainst the inner ring 21 and the rings are engaged together to maintainthe sealing engagement.

[0045] Fixing means for preventing rotation of the rings 21, 22 relativeto one another when the rings are in the sealing position illustrated inFIG. 7 is in this case provided by a plurality of projections 27 on oneof the rings, 22 which are engageable with a plurality of complimentaryshaped recesses 28 in the other rings 21 to lock the rings 21,22 againstrotation in the sealing position.

[0046] In use, an incision is first made in a patient 31. The cover 11is then removed and the flange 12 is adhesively bonded to the patientaround the incision as illustrated particularly in FIG. 4. The sleeve isarranged so that the exit opening 5 is aligned with the incision in thepatient 31. With the entry sealing means 20 in the open non-sealingconfiguration illustrated in FIGS. 3 and 5 a surgeon passes his hand andarm 30 through the entry 4 and the exit opening 5 to enter the patient'sbody through the incision. When the surgeon's arm 30 has passed throughthe sealing means 20 a desired distance, the outer ring 22 with thesealing body 23 attached is rotated to twist the sealing body 23 toengage against the surgeon's arm 30 until a relatively tight seal isobtained. The ring 22 is then pushed forwardly against the ring 21 andthe projections are engaged in the recesses 28 to lock the rings 21, 22together against rotation in the sealing configuration. In the case ofbowel resection surgery, gas is pumped into the patient's body cavitywhere the surgery is to be performed, the gas exiting through theincision in the patient and the opening 5 into the sleeve 2 to create acontrolled pressurised environment in the sleeve 2 in which the sleeve 2is inflated. The surgeon carries out the surgery as required and whencompleted the ring 22 is released from the ring 21 and contra-rotateduntil the flexible body 23 is in the non sealing position allowing thesurgeon to extract his hand through the sleeve 2.

[0047] There are many advantages of the invention. Because a surgeonneed only make a relatively small incision the trauma to the patient isminimised, there is less risk of damage to the immune system and thehealing time is short with a consequent decrease in the length of thehospital stay required. The techniques are considerably simpler thanconventional laproscopic surgical techniques and can be readilyperformed by a surgeon with minimal additional training. A wide range ofoperations can be performed using the apparatus of the invention.

[0048] Referring to FIG. 8 there is illustrated another apparatus foruse in surgery according to the invention indicated generally by thereference numeral 50. The apparatus 50 is similar to the apparatusdescribed above with reference to FIGS. 1 to 4 and like parts areassigned the same reference numerals. In this case the entry sealingmeans comprises a first ring 51 mounted to the sleeve 2 at the entry 4and a second separate ring 52 at the free end of a surgical glove 53.When a surgeon's arm with the glove 53 passes through the entry 5 therings 51, 52 are arranged to sealingly engage to create a controlledenvironment within the sleeve 2 during an operation.

[0049] Referring to FIG. 9 there is illustrated, a further apparatusaccording to the invention for use in surgery and indicated generally bythe reference, numeral 60. In this case, the exit sealing means,comprises a sealing diaphragm having a first ring 61 attached to thesleeve 2 and a flexible diaphragm 62 extending from the ring 61 andterminating in an inner ring 63 which is inserted through the incisionto engage with the body tissue 30 as illustrated. The sealing diaphragmseals the exit 5 of the sleeve 2 to the incision in the patient's bodyto create a controlled pressurised environment in the sleeve 2.

[0050] With reference to FIGS. 10 and 10a, the sleeve 70 is animpermeable and flexible sleeve, one end of which is configured toprovide a pressure tight seal against a surgeons forearm with the otherend configured to provide a pressure tight seal with a patients skin.With the sleeve 70, and integral with it, is a non-return valve 74, inthe form of a sealing cuff, permitting the removal of a surgeons handand forearm from the sleeve whilst maintaining pressure within apatients abdomen.

[0051] The sleeve 70, in overall shape and method of construction, issubstantially equivalent to known colostomy bags, a differing in thatits overall length is greater, there is the integral non-return valve 74and the open end permits attachment to a surgeons forearm. The sleevecomprises two layers of medical grade polyethylene, one with an orifice71, edge welded using a radio frequency (RF) welding technique. Anannular flange 72 of medical grade polyethelene, one surface of which iscoated with medical grade adhesive, is welded to the sleeve as shown.The non-return valve 74 comprises two layers of medical gradepolyethelene welded to the sleeve to form the valve indicated. The armattachment device consists of two rigid medical grade polyethelenecircular members 76,77 connected, as indicated, by a thin walledcylindrical tube 78 of elastomer (medical grade latex or similar).

[0052] Rotation of member 76 relative to 77 causes the latex tube toform an iris diaphragm effectively reducing the size of the arm accessopening. Attachment of member 77 to the sleeve is achieved using medicalgrade adhesive.

[0053] The technique of attachment of this device to a patient issimilar to that of a colostomy bag. The annular, adhesive coated flangeis applied to a patients skin such that the annulus encircles the accessincision. Adhesion may be assisted by the application of an adhesivesurgical drape prior to making said incision. Attachment to a surgeonsforearm is achieved by inserting a hand and forearm into the sleevethrough member 76. Rotation of member 76 relative to member 77 causes aniris diaphragm to form effectively gripping the forearm with theelastomer sleeve. Further movement of the hand towards opening 71 causesthe non-return valve 74 to open and access to the abdominal cavity ispossible through the access incision. Removal of a surgeons hand is inthe reverse order to that above with the result that the non-returnvalve 74 closes maintaining abdominal pressure.

[0054] It is anticipated that in some cases adhesive may be applied to apatient around the area of an incision to which a sealing ring of thesleeve is to be attached during preparations for an operation. Adhesivemay alternatively or additionally be applied to the ring to be attachedaround the area of an incision. Either or both layers of adhesive may becovered by a sterile wrapping material through which the incision may bemade. Either or both layers of adhesive may be provided with peel offcovers.

[0055] It will further be appreciated that the sleeve may incorporate anair lock to facilitate changing of an instrument and/or debris such ascancer cells during an operation without breaking the sterilisedenvironment in the sleeve.

[0056] The sleeve may be provided with more than one inlet opening for asurgeon's arms and/or instruments.

[0057] The sleeve may also be provided with means to create anintermediate pressurised environment by, for example, providing twoinlet sealing cuffs spaced-apart along the sleeve. The inner of thecuffs being sealed before the seal provided by the outer cuff is opened.

[0058] Referring to FIGS. 11 to 16, and initially to FIGS. 11 and 12there is illustrated a valve according to the invention indicatedgenerally by the reference numeral to which in this case is used inassociation with a trocar assembly comprising a trocar tube or cannula102 and a trocar 103.

[0059] The valve 101 comprises an outer ring which in this casecomprises a pair of axially facing ring 105, 106 and a sealing sleeve107 of a flexible material, the free ends 107 a, 107 b of which areattached to the respective ring parts 105, 106.

[0060] To form the valve 101 according to the invention, typically oneof the ring parts 105 is rotated relative to the other to twist theflexible sleeve 106 from a substantially cylindrical non-sealingconfiguration to an hourglass sealing configuration as illustratedparticularly in FIG. 12 having a central opening 108 through which amember such as a trocar 103 may be inserted. The ring parts 104, 106 areretained in the sealing configuration illustrated in FIG. 12 by anysuitable means such as by adhesive bonding or the like.

[0061] The valve 101 is typically housed in a seat 109 of a trocar tubeor cannula 102. To pass a member such as a trocar 103, operatinginstrument 110 or the like through the valve 101 in a trocar tube orcannula 102, the trocar 103 is first offered up to the opening 108 inthe sealing sleeve 107 and is pushed through the sleeve 107 by rotatingthe trocar 103 to ease the passage of the trocar through the sleeve bycontra-rotating the sealing sleeve 107 against the sealing twist toenlarge the opening 108. As the trocar 103 passes through the sleeve 108the sealing engagement is maintained.

[0062] A wide range of different size and types of members such astrocars or operating instruments may be readily passed through a singlevalve 101. For narrow members such as the instrument 110 illustrated inFIGS. 15 and 16 a collar 115 may be provided around the instrument 110,the collar 115 engaging against the sealing sleeve 107 of the valve 101to enlarge the opening 108 (see FIG. 5) allowing the collar 115 andinstrument 110 to readily pass therethrough (FIG. 16). In the insertedposition a shoulder 116 of the collar 115 engages against a stop 117 onthe tube 102. When it is desired to withdraw the instrument 10 from thetrocar tube 102, the instrument is drawn back to the collar 115 and thecollar 115 with the instrument 110 in frictional engagement therewith isdrawn back through the flexible sealing sleeve 107.

[0063] There are many advantages of the valve according to theinvention. For the particular surgical application described, a singletrocar tube may now be inserted into a body cavity allowing a wide rangeof different types and sizes of instruments to be inserted through thetube. Thus, there would be a reduction in the number of trocarassemblies required for a particular operation. In addition, because ofthe simplicity of construction and operation, the valve and trocar tubeor cannula are readily sterilisable and consequently re-usable.

[0064] It will be appreciated that while the invention has beenspecifically described for use with a trocar assembly, it has manydifferent applications and accordingly the invention is not limited tothe application of the valve to a trocar tube, cannula or trocarassembly.

[0065] It will be appreciated that an additional entry aid may beprovided as an alternative to or in addition to the collar justdescribed. The additional sealing may be provided by a plurality offlexible segments extending inwardly on the inlet side of, the valve,the segments being pushed forwardly on insertion of an instrument toengage against and open the valve to facilitate passage through thevalve.

[0066] The invention is not limited to the embodiments hereinbeforedescribed, which may be varied in construction and detail withoutdeparting from the scope of the invention as defined in the appendedclaims 1 to 24 which are incorporated in this description by reference.

1-24. (Canceled)
 25. A method of providing sealed access through anincision comprising: making an incision in a patient; providing asurgical device comprising a proximal ring, a distal ring, and a tubulardiaphragm extending between the proximal ring and the distal ring;coupling the surgical device to the patient solely by inserting thedistal ring through the incision such that the diaphragm extends throughand engages the incision, and the proximal ring is located outside ofthe incision; inserting an object through an entry seal assembly coupledto the proximal ring of the surgical device, through the diaphragm, andinto the patient; and sealing the object by the entry seal assembly. 26.A method as claimed in claim 25, wherein the object includes at leastpart of a human arm.
 27. A method as claimed in claim 25, wherein theobject includes at least part of an instrument.
 28. A method as claimedin claim 25, further including moving the entry seal assembly between aunsealed configuration and a sealed configuration, and locking the entryseal assembly in the sealed configuration.
 29. A method as claimed inclam 25, further including engaging a detached, separate first componentwith a second component, the first and second components forming theentry seal assembly.
 30. A method as claimed in claim 29, wherein thefirst component includes a surgical glove.
 31. A method as claimed inclam 25, wherein the entry seal assembly includes a first member and asecond member connected together by a sleeve member, the method furtherincluding rotating the first and second members relative to one anotherto seal the object.
 32. A method as claimed in claim 31, wherein thefirst member includes a first ring, and the second member includes asecond ring.
 33. A method as claimed in claim 32, wherein the first ringincludes a circular shape, and the second ring includes a circularshape.
 34. A method as claimed in claim 32, further including lockingthe first and second rings together in a sealing configuration.
 35. Amethod as claimed in claim 25, wherein the entry seal assembly includesa sleeve extending between a seal mechanism and the proximal ring of thesurgical device.
 36. A method as claimed in claim 25, wherein theproximal ring includes a circular shape, and the distal ring includes acircular shape.
 37. A method as claimed in claim 25, wherein theproximal ring, distal ring, and diaphragm have approximately the sameinner diameter.
 38. A method as claimed in claim 25, wherein the entryseal assembly engages a proximal-most portion of the surgical device.39. A method as claimed in claim 25, wherein the distal ring is largerthan the incision.
 40. A method as claimed in claim 25, furtherincluding biasing the tubular diaphragm against the incision.
 41. Asurgical device providing sealed access through an incision in apatient, the device comprising: a distal ring; a proximal ring; atubular diaphragm extending between the distal ring and the proximalring; a single patient coupling assembly forming the only couplingbetween the surgical device and the patient, the single patient couplingassembly including the distal ring, the proximal ring and the tubulardiaphragm; and an entry seal assembly coupled to the proximal ring. 42.A surgical device as claimed in claim 41, wherein the entry sealassembly is configured to receive and seal at least part of a human arm.43. A surgical device as claimed in claim 41, wherein the entry sealassembly is configured to receive and seal at least part of aninstrument.
 44. A surgical device as claimed in claim 41, wherein theentry seal assembly is movable between a unsealed configuration and asealed configuration, and the entry seal assembly includes a lockingassembly configured to secure the entry seal assembly in the sealedconfiguration.
 45. A surgical device as claimed in claim 41, wherein theentry seal assembly includes a first component and a second component,the first component being completely detachable from the secondcomponent.
 46. A surgical device as claimed in claim 45, wherein thefirst component includes a surgical glove.
 47. A surgical device asclaimed in clam 41, wherein the entry seal assembly includes a firstmember and a second member connected together by a sleeve member, thefirst and second members being rotatable relative to one another to sealthe object.
 48. A surgical device as claimed in claim 47, wherein thefirst member includes a first ring, and the second member includes asecond ring.
 49. A surgical device as claimed in claim 48, wherein thefirst ring includes a circular shape, and the second ring includes acircular shape.
 50. A surgical device as claimed in claim 48, whereinthe entry seal assembly includes a locking assembly configured to securethe first and second rings together.
 51. A surgical device as claimed inclaim 41, wherein the entry seal assembly includes a sleeve extendingbetween a seal mechanism and the proximal ring.
 52. A surgical device asclaimed in claim 41, wherein the proximal ring includes a circularshape, and the distal ring includes a circular shape.
 53. A surgicaldevice as claimed in claim 41, wherein the proximal ring, distal ring,and diaphragm have approximately the same inner diameter.
 54. A surgicaldevice as claimed in claim 41, wherein the entry seal assembly forms aproximal-most portion of the surgical device.
 55. A surgical device asclaimed in claim 41, wherein the distal ring is larger than theincision.
 56. A method of providing sealed access through an incisioncomprising: making an incision in a patient; providing a surgical devicecomprising a proximal ring, a distal ring, and a tubular diaphragmextending between the proximal ring and the distal ring; inserting thedistal ring through the incision such that the diaphragm extends throughthe incision and the proximal ring is located outside of the incision;engaging an entry seal assembly to the proximal ring of the surgicaldevice; inserting an object through the entry seal assembly anddiaphragm, and into the patient; and sealing the object by the entryseal assembly.
 57. A method as claimed in claim 56, wherein the objectincludes at least part of a human arm.
 58. A method as claimed in claim56, wherein the object includes at least part of an instrument.
 59. Amethod as claimed in claim 56, further including moving the entry sealassembly between a unsealed configuration and a sealed configuration,and locking the entry seal assembly in the sealed configuration.
 60. Amethod as claimed in clam 56, further including engaging a detached,separate first component with a second component, the first and secondcomponents forming the entry seal assembly.
 61. A method as claimed inclaim 60, wherein the first component includes a surgical glove.
 62. Amethod as claimed in clam 56, wherein the entry seal assembly includes afirst member and a second member connected together by a sleeve member,the method further including rotating the first and second membersrelative to one another to seal the object.
 63. A method as claimed inclaim 62, wherein the first member includes a first ring, and the secondmember includes a second ring.
 64. A method as claimed in claim 63,wherein the first ring includes a circular shape, and the second ringincludes a circular shape.
 65. A method as claimed in claim 63, furtherincluding locking the first and second rings together in a sealingconfiguration.
 66. A method as claimed in claim 56, wherein the entryseal assembly includes a sleeve extending between a seal mechanism andthe proximal ring of the surgical device.
 67. A method as claimed inclaim 56, wherein the proximal ring includes a circular shape, and thedistal ring includes a circular shape.
 68. A method as claimed in claim56, wherein the proximal ring, distal ring, and diaphragm haveapproximately the same inner diameter.
 69. A method as claimed in claim56, wherein the entry seal assembly engages a proximal-most portion ofthe surgical device.
 70. A method as claimed in claim 56, wherein thedistal ring includes a diameter that is larger than the incision.
 71. Amethod as claimed in claim 56, further including biasing the tubulardiaphragm against the incision.
 72. A surgical device providing sealedaccess through an incision in a patient, the device comprising: a distalring having a size larger than the incision; a proximal ring; a tubulardiaphragm extending between the distal ring and the proximal ring andconfigured to engage the incision to form a seal against the incision; asingle patient coupling assembly forming the only coupling between thesurgical device and the patient, the single patient coupling assemblyincluding the distal ring, the proximal ring and the tubular diaphragm;and an entry seal assembly coupled to the proximal ring.
 73. A surgicaldevice as claimed in claim 72, wherein the entry seal assembly isconfigured to receive and seal at least part of a human arm.
 74. Asurgical device as claimed in claim 72, wherein the entry seal assemblyis configured to receive and seal at least part of an instrument.
 75. Asurgical device as claimed in claim 72, wherein the entry seal assemblyis movable between a unsealed configuration and a sealed configuration,and the entry seal assembly includes a locking assembly configured tosecure the entry seal assembly in the sealed configuration.
 76. Asurgical device as claimed in claim 72, wherein the entry seal assemblyincludes a first component and a second component, the first componentbeing completely detachable from the second component.
 77. A surgicaldevice as claimed in claim 76, wherein the first component includes asurgical glove.
 78. A surgical device as claimed in clam 72, wherein theentry seal assembly includes a first member and a second memberconnected together by a sleeve member, the first and second membersbeing rotatable relative to one another to seal the object.
 79. Asurgical device as claimed in claim 78, wherein the first memberincludes a first ring, and the second member includes a second ring. 80.A surgical device as claimed in claim 79, wherein the first ringincludes a circular shape, and the second ring includes a circularshape.
 81. A surgical device as claimed in claim 79, wherein the entryseal assembly includes a locking assembly configured to secure the firstand second rings together.
 82. A surgical device as claimed in claim 72,wherein the entry seal assembly includes a sleeve extending between aseal mechanism and the proximal ring.
 83. A surgical device as claimedin claim 72, wherein the proximal ring includes a circular shape, andthe distal ring includes a circular shape.
 84. A surgical device asclaimed in claim 72, wherein the proximal ring, distal ring, anddiaphragm have approximately the same inner diameter.
 85. A surgicaldevice as claimed in claim 72, wherein the entry seal assembly forms aproximal-most portion of the surgical device.